SD Bioline Leptospira IgG/IgM - India CDSCO Medical Device Registration

SD Bioline Leptospira IgG/IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000665_ff2e09b20cf3acc08294500d0dff254e_c4b31b471267e05a3767cf18d558e8a9. This device is marketed under the brand name SD Urocolor. The license holder is Abbott Diagnostics Medical Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

SD Bioline Leptospira IgG/IgM

UID: IMP/IVD/2020/000665_ff2e09b20cf3acc08294500d0dff254e_c4b31b471267e05a3767cf18d558e8a9

Brand Name

SD Urocolor

License Holder

Abbott Diagnostics Medical Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The SD Bioline Leptospira IgG/IgM kit is a rapid qualitative test for the detection of antibodies of IgG and IgM specific to Leptospira interrogans in human serum or plasma